Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis

Exclusion Criteria

• •Patients who have a form of arthritis or arthropathy, other than RA, or any current inflammatory condition that might confound the assessments (e.g., other connective tissue diseases or Lyme disease).
• •Patients who have been enrolled in any investigational therapy study for the treatment of RA within 4 weeks prior to the start of the Treatment Period, or patients who are scheduled to receive investigational therapies or a plasma based apheresis procedure (e.g., a protein A column) for the treatment of RA during the course of the study.
• •Patients unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, or hepatic failure.
• •Patients with a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.
• •Note: Every attempt should be made to enroll patients who have adequate peripheral venous access.
• •Patients who have a known hypersensitivity or allergy to psoralen (methoxsalen).
• •Patients who have a known hypersensitivity or allergy to both heparin and citrate products.
• •Patients who are taking any of the following permitted DMARDs and biological agents and have not been on a stable dose for the specific indicated periods of time prior to screening: MTX for at least 8 weeks; leflunomide for at least 8 weeks; infliximab for at least 14 weeks; etanercept for at least 12 weeks; adalimumab for at least 12 weeks.
• •Patients who are taking any of the following permitted medications and have not been on a stable dose for at least 4 weeks prior to screening: NSAIDs; anakinra; hydroxychloroquine; chloroquine; sulfasalazine; D-penicillamine; gold salts; azathioprine; oral corticosteroids (greater than or equal to 15 mg/day, prednisone equivalent dose).
• •Patients whom the Investigator believes cannot be maintained on stable doses of permitted concomitant RA medications throughout the Treatment Period.
• •Patients who are taking any of the following prohibited medications: cyclophosphamide; chlorambucil; intramuscular (IM) or intravenous (IV) corticosteroid injection(s), within 4 weeks of screening; intra-articular corticosteroid injection(s) \> 60 mg prednisone equivalent total dose, within 4 weeks of screening.
• •Patients who have any known malignant disease (other than basal cell carcinoma) currently or within the last 5 years.
• •Patients who have a pre-existing blood dyscrasia such as bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia, or a coagulation disorder.
• •Patients with a persistent or severe infection within 12 weeks of screening.
• •Patients with a history of drug or alcohol abuse within 12 weeks of screening.
• •Patients with impaired hepatic function at screening as shown by abnormal liver function tests (LFT; i.e., aspartate transaminase \[AST\] or alanine transaminase \[ALT\] levels \> 2 x the upper limit of normal \[ULN\]).
• •Women who are pregnant or lactating.